Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction

Completed

• Conditions: Mammaplasty; Radiotherapy; Complications; Breast Implant; Complications; Transplant Failure
• Interventions: Radiation: Adjuvant Radiotherapy

• Registration Number: NCT04783818
• Lead Sponsor: Humanitas Clinical and Research Center

Brief Summary

For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life.

There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction.

Adjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes.

Despite the undoubted cancer benefits, several studies have shown the negative impact of radiotherapy on breast reconstruction.

However, there are few studies with a significant number that evaluate the effect of radiotherapy on the three types of reconstruction.

In particular, given the extreme variability in clinical approaches, there is no certainty about the best reconstructive timing compared to radiotherapy, the iterations with dermic matrices as well as the usefulness of ancillary procedures such as autologous adipose grafting.

The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the effect of radiotherapy on different reconstructive modes.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-06
• Primary Completion: 2020-11-23
• Study Completion: 2021-01-25
• Status Verified: 2021-03
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-05
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3200

Inclusion Criteria

• Patients subjected to mastectomy and immediate reconstruction directly with prostheses, in two times and by autologue flaps (TRAM, Latissimus Dorsi Flap, DIEP and any other method)

Exclusion Criteria

• Delayed prosthetic reconstruction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Autologous Reconstruction With Adjuvant Radiotherapy	Adjuvant Radiotherapy	-
One Stage Reconstruction With Adjuvant Radiotherapy	Adjuvant Radiotherapy	-
Two Stage Reconstruction With Adjuvant Radiotherapy	Adjuvant Radiotherapy	-

Primary Outcome Measures

Name	Time	Method
Reconstruction failure	2 years	Complication rate (as hematoma, seroma, prosthetic exposure, skin and fat necrosis) that resulted in explant (prosthetic, expander or flap)

Secondary Outcome Measures

Name	Time	Method
Reconstruction Complications	2 years	Rate of capsular contracture and rate of need for reintervention

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy